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Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70


OBJECTIVES:

Primary

- Determine the quality of life of older patients with locally advanced or metastatic
non-small cell lung cancer treated with docetaxel.

Secondary

- Determine the response rate in patients treated with this drug.

- Determine the overall survival and progression-free survival of patients treated with
this drug.

- Determine the mood status and autonomy of activity of patients treated with this drug.

- Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6
courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6
and 12 months after completion of study treatment.

PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer, including
adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combination of
these histologies

- Stage IIIB (i.e., pleural T4) disease

- Stage IV disease

- Recurrent disease after prior surgery or radiotherapy allowed provided disease
is in an area that was not previously irradiated

- Measurable disease by CT scan or MRI

- No symptomatic brain metastasis

- Activity of Daily Living Scale score ≥ 4

- Instrumental Autonomy of Daily Living Scale score ≥ 4

PATIENT CHARACTERISTICS:

Age

- 70 and over

Performance status

- Not specified

Life expectancy

- More than 3 months

Hematopoietic

- Neutrophil count > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 10 g/dL

Hepatic

- Transaminases < 1.5 times normal

- Bilirubin normal

- Alkaline phosphatase < 2.5 times normal

- Pre-albumin > 1.5 mg/dL

Renal

- Creatinine clearance > 30 mL/min

Cardiovascular

- No congestive heart failure

- No unstable angina pectoris

- No myocardial infarction within the past year

- No uncontrolled hypertension

- No uncontrolled high-risk arrhythmias

Gastrointestinal

- No active peptic ulcer

- No inflammatory bowel disease

Neurologic

- No history of dementia or seizures that would preclude giving informed consent

- No peripheral neuropathy ≥ grade 2

- No history of significant neurologic disorders

Immunologic

- No history of hypersensitivity to the study drug or drugs formulated with polysorbate
80

- No active uncontrolled infection

Other

- No history of psychotic disorders

- No uncontrolled diabetes mellitus

- No absolute contraindication to corticosteroid use

- No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix

- No geriatric depression scale score ≥ 12/15

- No familial, social, geographical, or psychological reason that would preclude study
follow up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for stage IIIB or IV non-small cell lung cancer

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent chronic treatment with corticosteroids except low-dose (i.e.,
methylprednisolone ≤ 20 mg/day or equivalent) treatment that was initiated > 6 months
ago

Radiotherapy

- See Disease Characteristics

Surgery

- See Disease Characteristics

Other

- More than 30 days since prior active participation in another therapeutic clinical
trial

- No other concurrent anticancer therapy

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of life

Safety Issue:

No

Principal Investigator

Pierre Fargeot, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Authority:

United States: Federal Government

Study ID:

CDR0000443593

NCT ID:

NCT00227708

Start Date:

June 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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